Posts Tagged ‘prevention’

In yesterday’s post, I examined the various types of skin cancer and their prevalence in the US. Melanoma is the most deadly form of skin cancer and its incidence is on the rise. In that post, I examined some of the ways to protect yourself from the types of UV radiation that cause skin damage and cancer. One of these protection methods is the use of sunscreen. Sunscreen matters because the data is clear that sun exposure is what is causing deadly skin cancers:

About 90 percent of nonmelanoma skin cancers are associated with exposure to ultraviolet (UV) radiation from the sun.

The vast majority of mutations found in melanoma are caused by ultraviolet radiation.

About 65 percent of melanoma cases can be attributed to ultraviolet (UV) radiation from the sun.

One or more blistering sunburns in childhood or adolescence more than double a person’s chances of developing melanoma later in life.

A person’s risk for melanoma doubles if he or she has had more than five sunburns at any age.

However, up until now, there has been very little regulation of the marketing of different sunscreens. It has been very difficult for the American public to know whether the sunscreen they were choosing was going to be effective in protecting them from both UVA and UVB rays. There was also little way to know how much protection you were really receiving and whether the claims like “waterproof” and “sunblock” were just marketing or really claims with research behind them. Why does this matter? Check out this video from the FDA:

How the New FDA Rules Will Help

Well, some of this is going to change next summer. Last week, the FDA announced new regulations of sunscreen. If sunscreens meet the new legal standards, they can use certain marketing phrases so that consumers know what level of protection will be provided by the product. For example, “[u]nder the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Image from FDA.gov

Image from FDA.gov

The FDA explains the impact of the new regulations with the following:

Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.

Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.

“Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.

Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.

Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

So what does this all mean? It means that if you want a sunscreen that will provide protection against both UVA and UVB, you need to choose one that says “broad spectrum” AND has a minimum SPF of 15. You also need to look for a time limit on the water resistance of the sunscreen. In the future, other regulations may take effect, including limiting the SPF claims to 50 since there is no evidence that a higher SPF offers greater protection. The impact of the current rules should be an easier way for consumers to know that they are getting the greatest possible protection from the sunscreen they buy.

The New Regulations Do Not Address the Safety of Ingredients

So, while the new sunscreens will make it clearer whether the sunscreen protects against both UVA and UVB rays and how long the sunscreen will remain water resistant, the regulations do not regulate the ingredients that comprise the sunscreens. The ingredients in the sunscreens have not been tested for safety. Dr. Len has written a blog on the American Cancer Society website that touches on this issue:

Many of the ingredients of sunscreens have been used for years, however the FDA acknowledged today that they have not been tested for safety using modern techniques. They did emphasize that the benefits of sunscreens containing these ingredients far outweigh the risks given their longstanding safety profile.

Nanoparticles present in sunscreen-especially those containing zinc and titanium oxides-have been another source of concern. It is the use of “nanotechnology” that has made these effective sunscreens more acceptable since they don’t leave you with that white, pasty look that inhibited their use in the past.

Although it appeared during a news conference this morning that the FDA is satisfied at this time that products containing nanoparticles such as zinc and titanium oxides are safe when used as directed based on scientific evidence, another representative seemed a bit more cautious in his comments at second briefing held a couple of hours later by stating that nanoparticles are still being evaluated for safety.

The FDA did say they will continue to examine the science and the data regarding sunscreen ingredients, and will advise consumers promptly should they find evidence to the contrary regarding their safety profile.

One interesting outcome of the FDA’s announcement was their statement that they will be seeking further information from manufacturers and others on the safety and effectiveness of aerosol sunscreens. The FDA apparently is concerned about inhalation risks as well as effectiveness in real-life use. This is a sunscreen delivery method that many of us (including me) use often because of ease and convenience, and the questions regarding safety and effectiveness are certain to get some notice.

As more and more people are educated and aware of the risks of skin cancer, the use of sunscreens will presumably rise. Does it worry you that the new regulations deal more with marketing issues and confirming that the sunscreens do work effectively to minimize exposure to UVA and UVB rays than with the safety of the ingredients that provide that protection? Do you agree that since the risk of skin cancer outweighs the potential risks caused by the ingredients?

Personally, I use sunscreen and put it on my children daily. However, I also go out of the way to try to use ones that seem to have the “safest” record in terms of the chemicals involved. I also choose to use sun-shirts and other protective clothing as much as possible when at the pool or beach to minimize the amount skin I have to cover with sunscreen. Okay – honestly – it is also to minimize the amount of sunscreen smearing that I have to do every day. In order to work effectively, you are really supposed to use a lot of sunscreen all over exposed skin. As much as possible, we try to spend out time outside during the early morning and late afternoon/evening to minimize the direct exposure.

What steps do you take to protect yourself from sun exposure? What about the idea that a certain amount of sun exposure is good for Vitamin D production? What about the new FDA regulations, do they may sense? Will you shop for sunscreen differently?

From the (guest) editor: Although today’s weather forecast is for thunderstorms, we should keep in mind that the summer season is upon us. It is time to protect one of our largest organs — our skin!

–Jason

The news last week about the new FDA regulations on sunscreen had me prepared to write a blog article this week about the changes. I wanted to clarify what the new rules will mean for consumers – how to choose the correct product, what the various claims actually mean about protection, whether safety has been considered. However, as I delved deeper into the topic, I realized that the first concern has to be sun exposure and cancer in general. There is too much information – medical and legal – out there for one post. So, I am going to write a brief series. The first topic – today – will be about the startling statistics about various skin cancers. I will discuss various types of skin cancers, their prevalence and the survival and death rates from these cancers. In future posts, I plan to examine the original issue – whether the new regulations will help consumers choose a product that will help protect from some of these risks and how these legal steps may fall short of the final goal. Finally, I will look at the issue of tanning beds. Should children or teens be allows to use them? What about parental consent? There are medical and legal ramifications surrounding the use of tanning beds – I will look at a few of those. Along the way, please comment and let me know your thoughts. Or, if you are just daydreaming about enjoying summer…you can let us know that too (for my own personal idea of a great summer vacation see today’s photo).

Not All Skin Cancer is Created Equal

Personally, I tend to lump all skin cancer together in my mind. Unfortunately, whether you are putting yourself at risk for or are diagnosed with squamous cell, basilar cell or malignant melanoma makes a big difference. The rates of these diseases and the survival statistics are dramatically different.

Skin cancer that forms in melanocytes (skin cells that make pigment) is called melanoma. Skin cancer that forms in the lower part of the epidermis (the outer layer of the skin) is called basal cell carcinoma. Skin cancer that forms in squamous cells (flat cells that form the surface of the skin) is called squamous cell carcinoma. Skin cancer that forms in neuroendocrine cells (cells that release hormones in response to signals from the nervous system) is called neuroendocrine carcinoma of the skin.

How Common are these Cancers?

According to the Skin Cancer Foundation, skin cancer is the most common form of cancer in the United States. Of the various types of skin cancer, basal cell carcinoma is the most common (2.8 million/year the US), followed by squamous cell carcinoma (700,000/year), and finally melanoma (115,000). However, the death rates caused by melanoma are much higher than the other types of cancer. The statistics on the Skin Cancer Foundation website are shocking (just a sampling):

One person dies of melanoma every hour (every 62 minutes).

One in 55 people will be diagnosed with melanoma during their lifetime.

Melanoma is the most common form of cancer for young adults 25-29 years old and the second most common form of cancer for young people 15-29 years old.

The incidence of many common cancers is falling, but the incidence of melanoma continues to rise at a rate faster than that of any of the seven most common cancers.Between 1992 and 2004, melanoma incidence increased 45 percent, or 3.1 percent annually.

An estimated 114,900 new cases of melanoma were diagnosed in the US in 2010 – 46,770 noninvasive (in situ) and 68,l30 invasive, with nearly 8,700 resulting in death.

Melanoma accounts for less than five percent of skin cancer cases, but it causes more than 75 percent of skin cancer deaths.

I was particularly taken by this last fact – while accounting for “less than five percent of skin cancer cases, [melanoma] causes more than 75 percent of skin cancer deaths.” This is startling because “[t]he survival rate for patients whose melanoma is detected early, before the tumor has penetrated the skin, is about 99 percent.” However, ‘”[t]he survival rate falls to 15 percent for those with advanced disease.” So the key here is clearly prevention and early detection.

Unfortunately, the melanoma incidence rate is rising annually. Melanoma is responsible for approximately 8,700 deaths a year in the US, as compared to rare deaths from basal cell carcinoma and approximately 2,500 deaths a year from squamous cell carcinoma. And this is not just a problem for those with light skin – the Skin Cancer Foundation explains that “[w]hile melanoma is uncommon in African Americans, Latinos, and Asians, it is frequently fatal for these populations.”

Given the high incidence rate and the high survival rate for early-diagnosed melanomas, it seems key that people should know the risks factors and causes for melanoma. The better the prevention, the less likely that you should develop this type of cancer. Secondly, if you are in a high-risk category, you should be seeing a dermatologist regularly since the key to survival is early detection.

Causes of Melanoma

The CDC provides confirmation that “[s]kin cancer is the most common form of cancer in the United States” and that the incidence of melanoma of the skin has “increased significantly by 3.1% per year from 1986 to 2006 among men” and 3% among woman from 1993 to 2006.Yet, we know many of the risk factors for melanoma.

The CDC reports that “[a]bout 65%-90% of melanomas are caused by exposure to ultraviolet (UV) light.” This is the kind of radiation that come from the sun – and tanning beds (more on that in a later post). There are three different types of ultraviolet light and two of them have a role to play in changing and damaging skin cells.

The three types of UV rays are ultraviolet A (UVA), ultraviolet B (UVB), and ultraviolet C (UVC)-

UVA is the most common kind of sunlight at the earth’s surface, and reaches beyond the top layer of human skin. Scientists believe that UVA rays can damage connective tissue and increase a person’s risk of skin cancer.

Most UVB rays are absorbed by the ozone layer, so they are less common at the earth’s surface than UVA rays. UVB rays don’t reach as far into the skin as UVA rays, but they can still be damaging.

UVC rays are very dangerous, but they are absorbed by the ozone layer and do not reach the ground.

Too much exposure to UV rays can change skin texture, cause the skin to age prematurely, and can lead to skin cancer. UV rays also have been linked to eye conditions such as cataracts.

Certainly, some of these risk factors are immutable, but others, like sun exposure and tanning are risks that can be avoided or at least minimized. The CDC says they have supported surveys that show that “U.S. youth and adults are being exposed to ultraviolet radiation and can do more to protect themselves. More than one-third of the U.S. population reported a sunburn in the previous year, with rates higher among men and the non-Hispanic white population.”

I found the CDC statistics troubling given how long it has been known that sun exposure and damage lead to skin cancer:

In 2005, only 56% of adults said they usually practice at least one of the three sun-protective behaviors (use sunscreen, wear sun-protective clothing, or seek shade).

30% reported usually applying sunscreen (27% applied sunscreen with an SPF of 15 or higher).

18% reported usually wearing some type of fully sun-protective clothing.

33% usually sought shade.

Only 43% of young adults aged 18-24 used one or more sun protective methods, whereas 58% of those 25 years of age and older reported using one or more methods. Among men 18 and older, only 47% reported usually using one or more methods of sun protection, in contrast to 65% of women 18 and older.

Among high school students, when they were outside for more than an hour on a sunny day-

11.7% of girls and 6.3% of boys reported they routinely used a sunscreen with an SPF of 15 or higher.

15.9% of girls and 20.5% of boys reported they routinely stayed in the shade, wore long pants, wore a long-sleeved shirt, or wore a hat that shaded their face, ears, and neck.

Nearly 9% of teens aged 14-17 years used indoor tanning devices. Girls aged 14-17 years were seven times more likely than boys in the same age group to use these devices.

The recommendations are clearly not being followed. To best protect yourself from sun damage, there are 3 simple steps:

Use Sunscreen

Wear Protective Clothing (including hats and sunglasses)

Find Shade

Do not forget that these tips are important whether you are at the beach or just around town and on both cloudy and sunny days. It is especially important to be careful during the peak times of 10 am to 4 pm.

Of course, “use sunscreen” is oversimplifying how to protect oneself. It is within this context that I will look into the various legal and marketing changes coming soon to sunscreens in my next post.

Did you know all of these facts about skin cancer? Did you know that melanoma was so common and so deadly, despite being very survivable when detected early?

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge.

The study details are fascinating, particularly in regards to the results. For example:

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

What I found most interesting, however, was that the study was not completed. The reported findings were the preliminary results from the clinical trials. In fact, the article explained that “[t]he data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.”

The way these results were discovered and released during the course of the study was what intrigued me. Here’s how the study data was described:

“[U]nblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

This means that the clinical trial was stopped before reaching completion so that all of the participating couples could receive treatment.

The implications of ending this trial short are complicated. For the participants, the decision can be nothing but positive since it may provide the study participants with the opportunity to receive treatment that could hopefully lead to a dramatically decreased likelihood of infection with a potentially deadly disease. For many others around the world who have a partner with H.I.V., the implications are likewise a boon for public health. The release of these early results may impact treatment of H.I.V. infected individuals around the world who may now be able to protect their partners from infection. However, the end of this study is not as clear-cut in terms of research and ethical implications as it might seem.

I originally became aware of the idea that clinical studies are sometimes cut short in the mid 1990s. My father, an occupational health doctor who died in 1999, was involved in the CARET studies during the 1990s. This large-scale double blind study was looking at whether beta-carotene and retinyl palmitate would be able to prevent lung cancer in heavy smokers and workers who had been exposed to asbestos. However, the study was ended prematurely based on interim results that suggested an adverse affect on the study participants. Since I was only a high school student at the time that the trial was ended, I did not know many of the details at the time. I understood the basic idea that if a medical research study was causing harm to the participants, that it must be ended. When I read the recent news about the H.I.V. treatment study, it prompted me to try to learn more about how and when clinical studies are interrupted.

There was an article published called “Stopping the active intervention: CARET” that I found enlightening about how and why the CARET studies were ended. The article provides an overview that I found helpful in thinking about the current H.I.V. study:

The optimal design of a randomized clinical intervention trial, where the outcome is a disease endpoint, includes a set of criteria for stopping the active intervention before planned. These criteria, called “stopping rules,” guide the review of findings by key study scientists and an independent set of reviewers. If the pattern of outcome, effect or harm, is large enough to be attributed to the intervention, the trial is halted, regardless of the planned completion date or the readiness of staff to end the trial.

While in the H.I.V. study, the impact was positive, rather than negative as in the CARET study, the procedure seems to be similar. A procedure in the study allowed for data to be unblinded and examined by an independent panel which then recommended that the trial be stopped early.

However, this does present two potential problems. One is that the study, scientifically speaking, did not reach its full conclusions. It may not provide as much evidence of implications as it might have if it had continued or if the study population had been larger. For example, the New York Times article mentioned the following:

Although the trial was relatively large, there are some limitations on interpreting the data.

More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.

“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.

Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.

Another implication is that the results may not be as scientifically accurate if the trials are stopped early. A study published in JAMA entitled “Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-regression Analysis” explains:

Although randomized controlled trials (RCTs) generally provide credible evidence of treatment effects, multiple problems may emerge when investigators terminate a trial earlier than planned, especially when the decision to terminate the trial is based on the finding of an apparently beneficial treatment effect. Bias may arise because large random fluctuations of the estimated treatment effect can occur, particularly early in the progress of a trial. When investigators stop a trial based on an apparently beneficial treatment effect, their results may therefore provide misleading estimates of the benefit. Statistical modeling suggests that RCTs stopped early for benefit (truncated RCTs) will systematically overestimate treatment effects, and empirical data demonstrate that truncated RCTs often show implausibly large treatment effects.

(internal footnotes omitted)

So, perhaps, if the trial were continued, the results would not have been as overwhelmingly positive. Perhaps the percentage of partners infected in the two groups would not have been as widely divergent. But perhaps they would – and would you want to gamble with someone’s life?

Have you ever been involved in a clinical research study that has been ended early? Was it for positive or negative results? What should be done to maximize public health and safety while still providing the benefits of full blind research studies?